QTX3034 in Patients With KRAS G12D Mutation

NCT06227377 | Recruiting Phase 1 FDA Drug

• 1 other identifier: QTX3034-001
• Study Type: interventional
• Target: 250
• Locations: 1 country
• Sites: 14

Brief Summary

Phase 1 study to determine the safety and tolerability of QTX3034 as a single agent or in combination with cetuximab.

Conditions

Solid Tumors

Outcome Measures

Primary Outcomes (2)

• Number of participants with Dose Limiting Toxicities (DLTs)

  DLTs will be defined as the occurrence of any of the toxicities as described in the protocol

  up to 21 days

• Number of participants with Treatment-emergent Adverse Events (TEAEs)

  Defined as adverse events reported for the first time or worsening of a pre-existing event after first dose of study drug monotherapy and in combination with cetuximab

  up to 2 years

Secondary Outcomes (3)

• QTX3034 pharmacokinetic parameters in plasma

  up to 2 years

• Objective response rate (ORR)

  up to 2 years

• Duration of response (DOR)

  up to 2 years

Study Arms (4)

Part 1a: QTX3034 monotherapy dose-escalation

EXPERIMENTAL

QTX3034 will be administered at protocol defined dose based on cohort assignment

Drug: QTX3034

Part 1b: QTX3034 combination with cetuximab dose-escalation

EXPERIMENTAL

QTX3034 will be administered at protocol defined dose in combination with cetuximab based on cohort assignment

Drug: QTX3034; Combination Product: Cetuximab

Part 2: QTX3034 monotherapy dose-expansion

EXPERIMENTAL

QTX3034 will be administered at protocol defined dose in combination with cetuximab based on cohort assignment

Drug: QTX3034

Part 3: QTX3034 combination with cetuximab dose-expansion

EXPERIMENTAL

QTX3034 will be administered at protocol defined dose in combination with cetuximab based on cohort assignment

Drug: QTX3034; Combination Product: Cetuximab

Interventions

QTX3034 DRUG

QTX3034 will be administered at protocol defined dose

Part 1a: QTX3034 monotherapy dose-escalation; Part 1b: QTX3034 combination with cetuximab dose-escalation; Part 2: QTX3034 monotherapy dose-expansion; Part 3: QTX3034 combination with cetuximab dose-expansion

Cetuximab COMBINATION_PRODUCT

Cetuximab will be administered at protocol defined dose.

Part 1b: QTX3034 combination with cetuximab dose-escalation; Part 3: QTX3034 combination with cetuximab dose-expansion

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Pathologically documented, locally advanced or metastatic malignancy with KRAS G12D mutation identified through molecular testing (NGS- or PCR-based) with a Clinical Laboratory Improvement Amendments-certified (or equivalent) diagnostic
• Part 1: - Advanced solid tumors with at least 1 prior systemic therapy
• Evaluable or Measurable disease per RECIST 1.1.
• Parts 2 and 3: Measurable disease per RECIST 1.1.
• Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1.
• Adequate organ function

You may not qualify if:

• Prior treatment with a KRAS inhibitor
• Active brain metastases or carcinomatous meningitis
• History of other malignancy within 2 years
• Significant cardiovascular disease
• Disease or disorder that may pose a risk to patient's safety

Sponsors & Collaborators

• Quanta Therapeutics: lead

Study Sites (14)

UCLA Hematology/Oncology

Los Angeles, California, 90095, United States

RECRUITING

Sarah Cannon Research Institute (SCRI)

Denver, Colorado, 80218, United States

RECRUITING

Yale Cancer Center

New Haven, Connecticut, 06511, United States

RECRUITING

Florida Cancer Specialists

Sarasota, Florida, 34232, United States

RECRUITING

Moffitt Cancer Center

Tampa, Florida, 33612, United States

RECRUITING

NYU Langone Health

New York, New York, 10016, United States

RECRUITING

Montefiore Medical Center

The Bronx, New York, 10461, United States

RECRUITING

Duke University

Durham, North Carolina, 27710, United States

RECRUITING

Stephenson Cancer Center

Oklahoma City, Oklahoma, 73104, United States

RECRUITING

SCRI- Nashville

Nashville, Tennessee, 37203, United States

RECRUITING

MD Anderson

Houston, Texas, 77030, United States

RECRUITING

START San Antonio, LLC

San Antonio, Texas, 78229, United States

RECRUITING

University of Utah, Huntsman Cancer Center

Salt Lake City, Utah, 84112, United States

RECRUITING

NEXT Oncology Virginia

Fairfax, Virginia, 22031, United States

RECRUITING

MeSH Terms

Interventions

Cetuximab

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Central Study Contacts

Quanta Therapeutics Clinical Trials

CONTACT

415-599-3892; clinicaltrials@quantatx.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 18, 2024
• First Posted: January 26, 2024
• Study Start: February 5, 2024
• Primary Completion (Estimated): April 1, 2027
• Study Completion (Estimated): April 1, 2027
• Last Updated: April 27, 2026

Record last verified: 2026-04

Locations

US (14)